InfertilityEevaNCT01369446
Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
An observational study of Infertility, run by Progyny, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Eeva System Study
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.
Who may be able to join
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- At least 18 years of age.
- Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
- Basal FSH < 10 IU.
- At least 8 normally fertilized eggs (2PN.)
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- Willing to comply with study protocol and procedures and able to speak English.
Who cannot join
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Gestational carriers.
- Use of reinseminated eggs.
- Concurrent participation in another clinical study.
- Previous enrollment in this clinical study.
- History of cancer.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
HRC Fertility
Encino, California, 91436
Stanford University
Palo Alto, California, 94304
Pacific Fertility Center
San Francisco, California, 94133
Fertility Physicians of Northern California
San Jose, California, 95124
Reproductive Science Center
San Ramon, California, 94583
About this study
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.
- Conditions
- Infertility
- Being tested
- Eeva System Study
- Keywords
- In vitro fertilization, Assisted reproduction, Noninvasive imaging of embryos, Time lapse imaging of embryos, Traditional morphological grading of embryos, Prediction of blastocysts
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eeva System StudyDevice
The Eeva System will image embryos through cleavage and/or blastocyst stage.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing IVF treatment | Not described Receives: Device: Eeva System Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.
Measured: Embryos cultured through blastocyst stage (Day 5).
Secondary outcomes (1)
Pregnancy Outcome
Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative.
Measured: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheua Shen, MD, ELD, Study director, Progyny, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369446
- Sponsor's protocol ID
- TST-1057-p
- Acronym
- Eeva
- Status last verified
- Jul 2012
- First submitted
- 7 Jun 2011
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3.
PubMed 20890283Athayde Wirka K, Chen AA, Conaghan J, Ivani K, Gvakharia M, Behr B, Suraj V, Tan L, Shen S. Atypical embryo phenotypes identified by time-lapse microscopy: high prevalence and association with embryo development. Fertil Steril. 2014 Jun;101(6):1637-48.e1-5. doi: 10.1016/j.fertnstert.2014.02.050. Epub 2014 Apr 14.
PubMed 24726214
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
- ClinicalTrials.gov ID
- NCT01369446
- Acronym / sponsor ID
- Eeva / TST-1057-p
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Assisted reproduction, Noninvasive imaging of embryos, Time lapse imaging of embryos, Traditional morphological grading of embryos, Prediction of blastocysts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF treatment | – | Device: Eeva System Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.
Key inclusion criteria (7 listed)
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- At least 18 years of age.
- Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
- Basal FSH < 10 IU.
- At least 8 normally fertilized eggs (2PN.)
Key exclusion criteria (6 listed)
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Gestational carriers.
- Use of reinseminated eggs.
- Concurrent participation in another clinical study.
- Previous enrollment in this clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eeva System StudyThe Eeva System will image embryos through cleavage and/or blastocyst stage. | Device | Women undergoing IVF treatment |
Primary outcome
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
Time frame: Embryos cultured through blastocyst stage (Day 5).
Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.
1 secondary outcome
Pregnancy Outcome
Time frame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
- Background: PubMed 20890283Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3.
- Derived from this study: PubMed 24726214Athayde Wirka K, Chen AA, Conaghan J, Ivani K, Gvakharia M, Behr B, Suraj V, Tan L, Shen S. Atypical embryo phenotypes identified by time-lapse microscopy: high prevalence and association with embryo development. Fertil Steril. 2014 Jun;101(6):1637-48.e1-5. doi: 10.1016/j.fertnstert.2014.02.050. Epub 2014 Apr 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheua Shen, MD, ELD study director
Progyny, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Progyny, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5. (time frame: Embryos cultured through blastocyst stage (Day 5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01369446, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.